U.S. patent application number 10/963354 was filed with the patent office on 2005-03-03 for one-branch stent-graft for bifurcated lumens.
Invention is credited to Kujawski, Dennis, Nazzaro, Patrice.
Application Number | 20050049676 10/963354 |
Document ID | / |
Family ID | 33511359 |
Filed Date | 2005-03-03 |
United States Patent
Application |
20050049676 |
Kind Code |
A1 |
Nazzaro, Patrice ; et
al. |
March 3, 2005 |
One-branch stent-graft for bifurcated lumens
Abstract
A stent-graft is provided that includes a bifurcated stent
adapted for placement at the bifurcation of a bifurcated body
lumen. The stent-graft further includes a graft that lines or
covers at least part of the bifurcated stent. The graft defines a
fluid passageway from the unbifurcated portion into one of the
bifurcated stent branches. A closure prevents fluid from flowing
through the second of the branches and into the other branch of the
body lumen.
Inventors: |
Nazzaro, Patrice; (Wayne,
NJ) ; Kujawski, Dennis; (Wayne, NJ) |
Correspondence
Address: |
RATNERPRESTIA
P O BOX 980
VALLEY FORGE
PA
19482-0980
US
|
Family ID: |
33511359 |
Appl. No.: |
10/963354 |
Filed: |
October 12, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10963354 |
Oct 12, 2004 |
|
|
|
10461898 |
Jun 13, 2003 |
|
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Current U.S.
Class: |
623/1.13 ;
623/1.35 |
Current CPC
Class: |
A61F 2/90 20130101; A61F
2002/067 20130101; A61F 2/07 20130101; A61F 2002/075 20130101 |
Class at
Publication: |
623/001.13 ;
623/001.35 |
International
Class: |
A61F 002/06 |
Claims
1. A stent-graft for bypassing one branch of a bifurcated body
lumen comprising: a bifurcated stent, wherein said stent includes
an unbifurcated portion and two branches extending therefrom, and
is adapted for placement with the bifurcation of the stent adjacent
the bifurcation of the body lumen and the two branches extending
into the branches of the bifurcated body lumen; a graft lining or
covering at least part of said bifurcated stent and defining a
fluid passageway from said unbifurcated portion into one of said
bifurcated stent branches; and a closure preventing fluid from
flowing to the other of said branches, wherein said closure is a
second stent-graft placed in said unbifurcated portion of said
bifurcated stent and extending into only one branch of said
bifurcated stent.
2. The stent-graft recited in claim 1, wherein said bifurcated
stent has a radially compressed configuration for introduction into
the bifurcated body lumen and a radially expanded configuration for
deployment within the bifurcated body lumen.
3. The stent-graft recited in claim 1, wherein said second
stent-graft has a radially compressed configuration for
introduction into said bifurcated stent and a radially expanded
configuration for deployment within said bifurcated stent.
4. A stent-graft, adapted for placement at a native vessel
bifurcation, comprising: a straight bifurcated stent including, a
proximal portion adapted for placement in an unbifurcated region of
the native bifurcation, two distal portions, the first of which is
adapted to extend from the unbifurcated region of the native
bifurcation into one of the bifurcated branches of the native
bifurcation, the second of which extends toward the other
bifurcated branch of the native bifurcation, and a graft lining or
covering which extends from said proximal portion of said straight
bifurcated stent to said distal portions of said straight
bifurcated stent; and a tapered stent including, a proximal tapered
portion adapted for placement in said proximal portion of said
straight bifurcated stent, a distal portion adapted for placement
in said first distal portion of said straight bifurcated stent, and
a graft lining or covering which extends from said proximal portion
of said tapered stent to said distal portion of said tapered stent,
wherein said tapered stent defines a fluid passage to said first
distal portion of said straight bifurcated stent, and is closed to
fluid passage into said second distal portion of said straight
bifurcated stent.
5. The stent-graft recited in claim 4, wherein said straight
bifurcated stent has a radially compressed configuration for
introduction into a lumen and a radially expanded configuration for
deployment within the lumen.
6. The stent graft recited in claim 4, wherein said tapered stent
has a radially compressed configuration for introduction into a
lumen and a radially expanded configuration for deployment within
the lumen.
Description
[0001] This application is a divisional of application Ser. No.
10/461,898 filed on Jun. 13, 2003 entitled ONE-BRANCH STENT-GRAFT
FOR BIFURCATED LUMENS.
FIELD OF THE INVENTION
[0002] The present invention relates to a one-branch stent-graft
for use in bifurcated body lumens. More specifically, the present
invention relates to a stent graft including two branches, wherein
a closure prevents fluid from flowing to one of the branches.
BACKGROUND OF THE INVENTION
[0003] A stent-graft (a stent with a graft layer lining or covering
it) is typically used to provide a prosthetic intraluminal wall,
e.g., in the case of a stenosis or aneurysm, to provide an
unobstructed conduit for blood in the area of the stenosis or
aneurysm. A stent-graft may be endoluminally deployed in a body
lumen, a blood vessel for example, at the site of a stenosis or
aneurysm by so-called "minimally invasive techniques" in which the
stent-graft is compressed radially inwards and is delivered by a
catheter to the site where it is required, through the patient's
skin, or by a "cut down" technique at a location where the blood
vessel concerned is accessible. When the stent-graft is positioned
at the correct location, the stent-graft is caused or allowed to
re-expand to a predetermined diameter in the vessel.
[0004] A one branch design stent-graft is typically utilized at a
native vessel bifurcation to direct fluid into only one of the
branches of the bifurcation. For example, an aorto-uni-iliac
stent-graft provides an unobstructed conduit for blood to flow from
the aorta through only one of the two iliacs. As used in the aorta,
blood flows through the single branch stent-graft to the bifurcated
vessel branch of the native bifurcation that contains the
stent-graft, while blood is prevented from flowing to the other
bifurcated branch of the native bifurcation.
[0005] Typical single branch design stent-grafts have a tendency to
work their way distally from the originally deployed position. It
will be appreciated by a person skilled in the art that it is
desirable to prevent stents from migrating out of position. In
particular, where the site of desired application of the stent or
prosthesis is a native vessel bifurcation, the distal migration
associated with the use of the prior art prostheses constitutes a
significant disadvantage.
SUMMARY OF THE INVENTION
[0006] A stent-graft of this invention includes a bifurcated stent,
i.e., an unbifurcated portion in fluid communication with two
branches. The stent-graft further includes a graft that lines or
covers at least part of the bifurcated stent. The graft of this
stent graft defines a fluid passageway from the unbifurcated
portion into one of the bifurcated stent branches. A closure, which
may be part of the graft, prevents fluid from flowing to the other
of the branches. The stent-graft is preferably adapted for
placement of the stent bifurcation adjacent the native bifurcation
of a body lumen to resist distal migration of the stent-graft. One
use of such stent-grafts is in bypassing abdominal aortic aneurysms
where a femoral-femoral bypass is surgically installed to provide
blood flow to the occluded iliac.
[0007] According to one aspect of this invention, a stent-graft is
provided that is adapted for placement at a native vessel
bifurcation. The stent-graft includes a bifurcated stent with a
proximal portion adapted for placement in an unbifurcated region of
the native bifurcation. As used herein, the term "proximal" means
the unbifurcated end of the stent or stent-graft, i.e., nearest to
the heart when the bifurcated lumen is the abdominal aorta, and the
term "distal" means the opposite, i.e., the bifurcated end of the
stent or stent-graft. The bifurcated stent further includes two
distal portions. The first distal portion is adapted to extend from
the unbifurcated region of the native bifurcation into one of the
bifurcated branches of the native bifurcation. The second distal
portion extends toward and into the other bifurcated branch of the
native bifurcation. A graft lining defines a fluid passage that
extends from the proximal portion of the bifurcated stent to the
first distal portion of the bifurcated stent. The graft lining is
closed to the other of the bifurcated branches.
[0008] According to yet another aspect of this invention, a
stent-graft adapted for placement at a native vessel bifurcation
includes a bifurcated stent with a proximal portion adapted for
placement in an unbifurcated region of the native bifurcation. The
bifurcated stent further includes two distal portions. The first
distal portion is adapted to extend from the unbifurcated region of
the native bifurcation into one of the bifurcated branches of the
native bifurcation. The second distal portion extends toward and
into the other bifurcated branch of the native bifurcation. A graft
lining or covering defines a fluid passage that extends from the
proximal portion of the bifurcated stent to the distal portions of
the bifurcated stent. An occluder device is adapted for placement
in the second distal portion. The occluder prevents fluid passage
through the second distal portion of the bifurcated stent-graft and
to the second branch of the bifurcated lumen.
[0009] According to another aspect of this invention, a stent-graft
is provided that is adapted for placement at a native vessel
bifurcation. The stent-graft includes a straight bifurcated
stent-graft and a tapered stent-graft. The straight bifurcated
stent-graft includes a proximal portion adapted for placement in an
unbifurcated region of the native bifurcation, and two distal
portions. The first distal portion is adapted to extend from the
unbifurcated region of the native bifurcation into one of the
bifurcated branches of the native bifurcation. The second distal
portion extends toward and into the other bifurcated branch of the
native bifurcation. A graft lining or covering extends from the
proximal portion of the straight bifurcated stent-graft to the
distal portions of the straight bifurcated stent-graft. The tapered
stent-graft includes a proximal tapered portion and a distal
portion. The proximal portion is adapted for placement in the
unbifurcated portion of the straight stent-graft and the distal
portion is adapted for placement in the first distal portion of the
straight stent-graft. A graft lining or covering extends from the
proximal portion of the tapered stent-graft to the distal portion
of the tapered stent-graft. The tapered stent-graft defines a fluid
passage to the first distal-portion of the straight bifurcated
stent-graft, and is closed to fluid passage into the second distal
portion of the straight bifurcated stent-graft by the graft lining
or covering of the tapered stent-graft.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The aspects, features, and advantages of the present
invention will be more readily understood from the following
detailed description when read in conjunction with the accompanying
drawings, in which:
[0011] FIG. 1A is a front view of a stent-graft including a
bifurcated stent and a graft lining in accordance with one
embodiment of the present invention;
[0012] FIG. 1B is a detail view of the bifurcated stent of FIG.
1A;
[0013] FIG. 1C is a detail view of the graft lining of FIG. 1A;
[0014] FIG. 2A is a front view of a stent-graft including a
bifurcated stent, a graft lining, and an occluder device in
accordance with another embodiment of the present invention;
[0015] FIG. 2B is a detail view of the bifurcated stent of FIG.
2A;
[0016] FIG. 2C is a detail view of the graft lining of FIG. 2A;
[0017] FIG. 2D is a detail view of the occluder device of FIG.
2A;
[0018] FIG. 3A is a front view of a stent-graft including a
straight bifurcated stent and graft and a tapered stent and graft
in accordance with yet another embodiment of the present
invention;
[0019] FIG. 3B is a detail view of the straight bifurcated stent
and graft of FIG. 3A; and
[0020] FIG. 3C is a detail view of the tapered stent and graft of
FIG. 3A.
DETAILED DESCRIPTION OF THE INVENTION
[0021] Although the invention is illustrated and described herein
with reference to specific embodiments, the invention is not
intended to be limited to the details shown. Rather, various
modifications may be made in the details within the scope and range
of equivalents of the claims and without departing from the true
spirit and scope of the present invention.
[0022] Referring specifically to FIGS. 1A-1C, there is shown a
stent-graft 10 is adapted for placement at a native vessel
bifurcation. The stent-graft 10 includes a bifurcated stent 12 with
a proximal portion 14 adapted for placement in an unbifurcated
region of the native bifurcation. The bifurcated stent 12 further
includes two distal portions 16, 18. The first distal portion 16 is
adapted to extend from the unbifurcated region of the native
bifurcation into one of the bifurcated branches of the native
bifurcation. The second distal portion 18 extends toward the other
bifurcated branch of the native bifurcation. A graft lining 20
defines a fluid passage that extends from the proximal portion 14
of the bifurcated stent 12 to the distal portion 16 of the
bifurcated stent 12. The graft lining 20 is adapted to extend to
one of the bifurcated branches of the native bifurcation, but is
closed to the other of the bifurcated branches. The stent-graft 10
is adapted for placement of the stent bifurcation 22 adjacent the
native bifurcation.
[0023] FIG. 1B is a detail view of the bifurcated stent 12
illustrated in FIG. 1A. Typically, the bifurcated stent 12 has a
radially compressed configuration for introduction into a lumen,
and a radially expanded configuration for deployment within the
lumen. In other words, the bifurcated stent 12 is compressed
radially inwards and is delivered by a catheter to the site where
it is required through the patient's skin, or by a "cut down"
technique in which the blood vessel concerned is exposed by minor
surgical means at an accessible location thereof. When the stent 12
is positioned at the correct location, the stent 12 is caused or
allowed to re-expand to a predetermined diameter in the vessel and
the catheter is withdrawn.
[0024] FIG. 1C is a detail view of the graft lining 20 illustrated
in FIG. 1A. The graft lining 20 is attached to an inside surface of
the bifurcated stent 12 (as illustrated in FIG. 1A) by sewing,
suturing, or bonding.
[0025] In use, the stent-graft 10 illustrated in FIG. 1A is
juxtaposed or extends across a bifurcation in an artery or vein
such as, for example, the bifurcation in the mammalian aortic
artery into the common iliac arteries. Such bifurcation is referred
to throughout this specification as a native vessel bifurcation. In
the case of an abdominal aortic aneurysm ("AAA") in the infrarenal
portion of the aorta, which extends into one of the common iliac
arteries, the stent-graft 10 is deployed such that the stent
bifurcation 22 is placed adjacent the native vessel bifurcation.
The first distal portion 16 extends into one of the bifurcated
branches of the native bifurcation, while the second distal portion
18 extends toward and into the other bifurcated branch of the
native bifurcation. The tapered shape of the graft lining 20
results in a fluid passage that extends from the proximal portion
14 of the bifurcated stent 12 to the first distal portion 16 of the
bifurcated stent 12. In other words, blood flows through the
stent-graft 10 to the bifurcated vessel branch of the native
bifurcation that contains the first distal portion 16, while blood
is prevented from flowing through the stent-graft 10 to the other
bifurcated branch of the native bifurcation that contains the
second distal portion 18.
[0026] Accordingly, the second distal portion 18 functions not as a
fluid passageway, but as a structural member. The relationship
among the first distal. portion 16, the stent bifurcation 22, and
the second distal portion 18, allows the stent graft 10 to straddle
or span the native vessel bifurcation when deployed, placing the
stent bifurcation 22 adjacent the native vessel bifurcation tending
to prevent distal migration. Actual contact between the stent
bifurcation 22 and the native vessel bifurcation may prevent the
stent-graft 10 from working its way down away from its originally
deployed position.
[0027] In this and other embodiments of the present invention, the
stent and graft, respectively, may be formed of conventional
materials, such as nitinol and ePTFE.
[0028] Referring to FIGS. 2A-2D, there is shown another stent-graft
30, adapted for placement at a native vessel bifurcation, includes
a bifurcated stent 32 with a proximal portion 34 adapted for
placement in an unbifurcated region of the native bifurcation. The
bifurcated stent 32 further includes two distal portions 36 and 38.
The first distal portion 36 is adapted to extend from the
unbifurcated region of the native bifurcation into one of the
bifurcated branches of the native bifurcation. The second distal
portion 38 extends toward and into the other bifurcated branch of
the native bifurcation. A graft lining or covering 40 (graft
covering 40 is represented in FIG. 2A) defines a fluid passage that
extends from the proximal portion 34 of the bifurcated stent 32 to
the distal portions 36 and 38 of the bifurcated stent 32. An
occluder device 42 is adapted for placement in the second distal
portion 38. The occluder 42 prevents fluid passage through the
second distal portion 38 and to one of the bifurcated branches of
the native bifurcation. The stent-graft 30 is adapted for placement
of the stent bifurcation 44 adjacent the native bifurcation.
[0029] FIG. 2B is a detail view of the bifurcated stent 32
illustrated in FIG. 2A. The bifurcated stent 32 has a radially
compressed configuration for introduction into a lumen, and a
radially expanded configuration for deployment within the lumen. In
other words, the bifurcated stent 32 is compressed radially inwards
and is delivered by a catheter to the site where it is required
through the patient's skin, or by a "cut down" technique in which
the blood vessel concerned is exposed by minor surgical means. When
the stent 32 is positioned at the correct location, the stent 32 is
caused or allowed to re-expand to a predetermined diameter in the
vessel.
[0030] FIG. 2C is a detail view of the graft lining or covering 40
illustrated in FIG. 2A. The graft lining or covering 40 may be
attached to an inside surface of the bifurcated stent 32,
functioning as a lining. Alternatively, the graft lining or
covering 40 may be attached to an outside surface of the bifurcated
stent 32 (as illustrated in FIG. 2A), functioning as a
covering.
[0031] FIG. 2D is a detail view of one form of occluder useful in
combination with stent graft 30. Specifically shown is an occluder
device 42 comprising a closed, straight stent-graft, typically
adapted for endoluminal delivery into the second distal portion 38
of the bifurcated stent 32 after the stent-graft 30 has been
deployed and expanded. Similar to the bifurcated stent 32, occluder
device 42 has a radially compressed configuration for introduction
into a lumen, and a radially expanded configuration for deployment
within the lumen. Occluder device 42 includes a stent 43 and a
graft 44, either lining or covering part or all of stent 43 (as
illustrated in FIGS. 2A and 2D). Graft 43, however, is closed at
one end to occlude fluid flow through the occluder device 42 and
thus through the second distal portion 38 of the stent-graft
30.
[0032] In use, stent-graft 30 is juxtaposed or extends across a
bifurcation in an artery or vein. Bifurcated stent 32 is deployed
such that stent bifurcation 44 is placed near or adjacent the
native vessel bifurcation. First distal portion 36 extends into one
of the bifurcated branches of the native bifurcation, while the
second distal portion 38 extends toward and into the other
bifurcated branch of the native bifurcation. After stent-graft 30
has been deployed and expanded, occluder device 42 is placed in the
second distal portion 38 of the bifurcated stent 32, so that graft
43 defines a closed fluid passage, by which occluder device 42
prevents fluid from flowing through second distal portion 38 of
bifurcated stent 32. Such a configuration results in a fluid
passage that extends from proximal portion 34 of bifurcated stent
32 to first distal portion 36 of bifurcated stent 32. In other
words, blood flows through the stent-graft 30 to the bifurcated
vessel branch of the native bifurcation that contains the first
distal portion 36, while blood is prevented from flowing through
stent-graft 30 to the other bifurcated branch of the native
bifurcation that contains second distal portion 38.
[0033] Accordingly, second distal portion 38 of stent 34 functions
not as a fluid passageway, but as a structural member. The
relationship among the first distal portion 36, the stent
bifurcation 44, and the second distal portion 38, allows
stent-graft 30 to straddle or span the native vessel bifurcation
when deployed, placing the stent bifurcation 44 adjacent the native
vessel bifurcation. Such a configuration tends to resist distal
migration. Preferably, contact between the stent bifurcation 44 and
the native vessel bifurcation prevents the stent-graft 30 from
working its way down away from its originally deployed
position.
[0034] Referring to FIGS. 3A-3C, there is shown a stent-graft 50
adapted for placement at a native vessel bifurcation. Stent-graft
50 includes a straight bifurcated stent-graft 52 and a tapered
stent-graft 54. Straight bifurcated stent-graft 52 includes a
proximal portion 56 adapted for placement in an unbifurcated region
of the native bifurcation, and two distal portions 58 and 60. First
distal portion 58 is adapted to extend from the unbifurcated region
of the native bifurcation into one of the bifurcated branches of
the native bifurcation. Second bifurcation 60 extends toward and
into the other bifurcated branch of the native bifurcation. A graft
lining or covering 62 (graft covering 62 is represented in FIG. 3B)
extends from proximal portion 56 of straight bifurcated stent-graft
52 to distal portions 58 and 60 of straight bifurcated stent-graft
52. Tapered stent-graft 54 includes a proximal tapered portion 64
and a distal portion 66. Distal portion 66 is adapted for
placement, after the straight stent-graft 52 has been deployed and
expanded, in proximal portion 56 and first distal portion 58 of
straight bifurcated stent-graft 52. A graft lining or covering 68
(graft covering 68 is represented in FIG. 3A) extends from proximal
portion 64 of the tapered stent-graft 54 to distal portion 66 of
tapered stent-graft 54. Tapered stent-graft 54 defines a closed
fluid passage to first distal portion 58 of straight bifurcated
stent-graft 52, and is closed to fluid passage into second distal
portion 60 of straight bifurcated stent-graft 52.
[0035] FIGS. 3B and 3C are detail views of the straight bifurcated
stent-graft 52 and the tapered stent-graft 54, respectively,
illustrated in FIG. 3A. Both stent-grafts 52 and 54 have a radially
compressed configuration for introduction into a lumen, and a
radially expanded configuration for deployment within the lumen. In
other words, the stent-grafts 52 and 54 are compressed radially
inwards and are delivered by a catheter to the site where it is
required through the patient's skin, or by a "cut down" technique
in which the blood vessel concerned is exposed by minor surgical
means. When the stent-grafts 52 and 54 are positioned at the
correct location, the stent-grafts 52 and 54 are caused or allowed
to re-expand to a predetermined diameter in the vessel.
[0036] Graft linings or coverings 62 and 68 may be attached to an
inside surface of each respective stent 52 and 54, functioning as
linings. Alternatively, graft linings or coverings 62 and 68 may be
attached to an outside surface of each respective stent 52 and 54
(as illustrated in FIGS. 3A-3B), functioning as a covering.
[0037] In use, the stent-graft 50 illustrated in FIG. 3A is
juxtaposed or extends across a bifurcation in an artery or vein.
The straight bifurcated stent-graft 52 is deployed such that the
stent bifurcation 70 is placed near or adjacent the native vessel
bifurcation. The first distal portion 58 extends into one of the
bifurcated branches of the native bifurcation, while the second
distal portion 60 extends into the other bifurcated branch of the
native bifurcation. The tapered stent-graft 54 is positioned such
that the distal portion 66 is placed in proximal portion 56 and in
first distal portion 58 of straight bifurcated stent-graft 52.
Graft lining or covering 68 of tapered stent-graft 54 defines a
fluid passage that extends from proximal portion 56 of the straight
bifurcated stent-graft 52 to first distal portion 58 of the
straight bifurcated stent-graft 52. In other words, blood flows
through the stent graft 50 exclusively to the bifurcated vessel
branch of the native bifurcation that contains the first distal
portion 58, while blood is prevented from flowing through the
stent-graft 50 to the other bifurcated branch of the native
bifurcation that contains second distal portion 60.
[0038] Accordingly, second distal portion 60 functions not as a
fluid passageway, but as a structural member. The relationship
among the first distal portion 58, the stent bifurcation 70, and
the second distal portion 60, allows the stent-graft 50 to straddle
or span the native vessel bifurcation when deployed, placing the
stent bifurcation 70 adjacent the native vessel bifurcation to
prevent distal migration of the device. Contact between the stent
bifurcation 70 and the native vessel bifurcation may prevent
stent-graft 50 from working its way down away from its originally
deployed position.
[0039] While certain embodiments of the invention have been shown
and described herein, it will be understood that such embodiments
are provided by way of example only. Other embodiments may be
devised by those skilled in the art utilizing the essential novelty
of the invention as disclosed herein. It is intended that the
appended claims be construed to include all such embodiments,
whether or not disclosed herein.
* * * * *